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510(k) K173833

CRP Vario by SENTINEL CH. SpA — Product Code NQD

K173833 is an FDA 510(k) premarket notification submitted by SENTINEL CH. SpA for the device "CRP Vario". The FDA issued a decision of Substantially Equivalent on September 27, 2018. The device falls under product code NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. SENTINEL CH. SpA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2018
Date Received
December 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.

Other clearances by SENTINEL CH. SpA

  • K242585 — Cystatin C (May 16, 2025)
  • K211058 — Lp(a) Ultra (December 22, 2022)
  • K193001 — Albumin BCP (December 19, 2019)
  • K192118 — CRP Vario (November 8, 2019)
  • K141728 — ACE CALIBRATOR (July 28, 2014)
  • K102706 — CKMB UDR ASSAY (August 19, 2011)
  • K083602 — KAPPA LIGHT CHAINS (September 3, 2009)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K081533 — SENTINEL PLASMAPROTEINS CAL 3X (June 25, 2008)
  • K073634 — MULTIGENT CREATININE (ENZYMATIC) ASSAY (June 19, 2008)

Other clearances for product code NQD

  • K260026 — Tina-quant Cardiac high sensitivity CRP III (April 2, 2026)
  • K233242 — Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (January 18, 2024)
  • K212559 — CardioPhase® hsCRP (December 16, 2022)
  • K081294 — ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRA (July 29, 2008)
  • K071002 — IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP (June 21, 2007)
  • K070626 — SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT (May 4, 2007)
  • K071017 — IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5 (May 2, 2007)
  • K062924 — STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK (December 26, 2006)
  • K063057 — IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP (December 22, 2006)
  • K061802 — DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, (September 11, 2006)

FDA data resources